Clinical Research Coordinator II - Research Institute

Cedars-Sinai Medical Center•Los Angeles, CA

1d•Onsite

About The Position

Grow your career at Cedars Sinai! Cedars Sinai offers a culture of happiness, passion, and dedication. This is one of the many reasons why we rank as one of the top hospitals in California and in the nation by U.S. News & World Report. Do you have a passion for helping human kind? The Clinical and Translational Science Institute (CTSI) aligns its strengths to support clinical and translational science that fully partners with—and responds to—the needs of our Los Angeles community. The CTSI bridges disciplinary and institutional boundaries to create transdisciplinary teams focused on the greatest opportunities and the greatest needs in our region. The Clinical Research Coordinator II works independently providing study coordination including screening of patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Requirements

High School Diploma/GED, required.
2 years of clinical research experience, required.

Nice To Haves

Bachelor's degree in Science, Sociology, or related field is preferred.
ACRP/SoCRA certification is preferred.

Responsibilities

Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Schedules and participates in monitoring and auditing activities.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.